CoughNCT01515280
Hull Airway Reflux Questionnaire Scores Following Cough Treatment
An observational study of Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cough
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients attending chronic cough clinics
Who may be able to join
- Male/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.
- Willing and able to comply with study procedures
- Able to provide written informed consent to participate
Who cannot join
- 1. Any subject meeting any exclusion criteria on the study "A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough." Will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull and East Yorkshire Hospitals Trust
Cottingham, East Riding Of Yorkshire, HU16 5JQ
About this study
Official title: Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough."
The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.
- Conditions
- Cough
- Keywords
- chronic cough
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic cough | Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hull Airway Reflux Questionnaire score
The primary objective is to evaluate the effectiveness of HARQ in measuring a clinically significant change in HARQ score from baseline following 14 days treatment.
Measured: baseline and 2 weeks later
Secondary outcomes (1)
HARQ SCORES
The Key secondary endpoint will be to evaluate ability of HARQ in demonstrating a clinically significant change in score from baseline in the BC036 arm compared to Placebo arm of main study.
Measured: baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alyn H Morice, MD, Mphil, Principal investigator, Hull and EastYorkshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515280
- Sponsor's protocol ID
- 11112011
- Status last verified
- Jul 2019
- First submitted
- 18 Jan 2012
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Morice AH, McGarvey L, Pavord ID, Higgins B, Chung KF, Birring SS. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18.
PubMed 28839984
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough."
- ClinicalTrials.gov ID
- NCT01515280
- Acronym / sponsor ID
- 11112011
- Conditions
- Cough
- Keywords
- chronic cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic cough | – | –Patients taking part in supplementary study must be randomised to main study which includes a placebo arm and treatment arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients attending chronic cough clinics
Key inclusion criteria (3 listed)
- Male/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.
- Willing and able to comply with study procedures
- Able to provide written informed consent to participate
Key exclusion criteria (1 listed)
- 1. Any subject meeting any exclusion criteria on the study "A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough." Will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hull Airway Reflux Questionnaire score
Time frame: baseline and 2 weeks later
The primary objective is to evaluate the effectiveness of HARQ in measuring a clinically significant change in HARQ score from baseline following 14 days treatment.
1 secondary outcome
HARQ SCORES
Time frame: baseline and 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Results publication: PubMed 28839984Morice AH, McGarvey L, Pavord ID, Higgins B, Chung KF, Birring SS. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18.
- Publication LinkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyn H Morice, MD, Mphil principal investigator
Hull and EastYorkshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hull Airway Reflux Questionnaire score (time frame: baseline and 2 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.